US9844580B2ActiveUtilityPatentIndex 45

Recombinant human CC10 and compositions thereof for use in the treatment of nasal rhinitis

Assignee: THERABRON THERAPEUTICS INCPriority: May 13, 2008Filed: Feb 12, 2016Granted: Dec 19, 2017

Est. expiryMay 13, 2028(~1.9 yrs left)· nominal 20-yr term from priority

A61P 31/04A61P 29/00A61P 31/00A61K 9/0043A61P 11/02A61K 45/06A61K 38/17A61P 11/00A61K 38/1709A61K 47/02A61K 47/10C07K 14/47A61K 38/16C07K 14/435A61K 2300/00A61K 47/186

PatentIndex Score

Cited by

224

References

Claims

Abstract

The present invention relates generally to the use of recombinant human CC10 (rhCC10), also known as recombinant human uteroglobin, for use as a therapeutic in the treatment of nasal rhinitis, nasal sinusitis, chronic rhinosinusitis, and nasal polyposis. More particularly, the invention provides methods, including broadly the critical dosage ranges of rhCC10 and intranasal route of administration, which may be administered to safely and effectively treat the aforementioned conditions. The invention further provides a composition useful in administering rhCC10 to humans.

Claims

exact text as granted — not AI-modified

The invention claimed is: 
     
       1. A method of treating rhinosinusitis caused by infection in the nasal passages of a patient comprising: administering recombinant human Clara Cell 10 kDa protein (“rhCC10”) at a concentration no greater than 2 milligrams/milliliter onto an intranasal mucosal membrane of a patient. 
     
     
       2. The method of  claim 1  wherein the amount of rhCC10 administered is between 1.5 micrograms and 1.5 milligrams per day. 
     
     
       3. The method of  claim 1  wherein the amount of rhCC10 administered is less than 1.1 milligrams per day. 
     
     
       4. The method of  claim 1  wherein the amount of rhCC10 administered is 0.75 micrograms to 650 micrograms per day. 
     
     
       5. The method of  claim 1 , wherein the amount of rhCC10 administered is 0.5 micrograms to 370 micrograms per day. 
     
     
       6. The method of  claim 1  wherein the rhCC10 is administered three times per day. 
     
     
       7. The method of  claim 1  wherein the rhCC10 is administered two times per day. 
     
     
       8. The method of  claim 1  wherein the rhCC10 is administered to the nasal passages by instillation, lavage, swab applicator, or spray. 
     
     
       9. The method of  claim 1  wherein the rhCC10 is administered in combination with an antibiotic, an anti-histamine, a decongestant, a mucolytic, an analgesic, a local-acting vasoconstrictor, a leukotriene receptor antagonist, a steroid, a nasal excipient, or any combination thereof. 
     
     
       10. The method of  claim 1 , wherein the rhCC10 is administered at a concentration of 250 micrograms per milliliter in 0.65% sodium chloride, disodium phosphate, phenylcarbinol, monosodium phosphate, and benzalkonium chloride at a pH of 4.0-8.0. 
     
     
       11. The method of  claim 1  wherein rhCC10 is administered in the pharmaceutical composition in a dosage of 20-50 micrograms per nostril up to four times per day. 
     
     
       12. A method of slowing growth or regrowth of nasal polyps caused by infection in a patient comprising: administering rhCC10 at a concentration no greater than 2 milligrams/milliliter onto an intranasal mucosal membrane of a patient. 
     
     
       13. The method of  claim 12  wherein the amount of rhCC10 administered is between 1.5 micrograms and 1.5 milligrams per day. 
     
     
       14. The method of  claim 12  wherein the amount of rhCC10 administered is less than 1.1 milligrams per day. 
     
     
       15. The method of  claim 12  wherein the amount of rhCC10 administered is 0.75 micrograms to 650 micrograms per day. 
     
     
       16. The method of  claim 12  wherein the amount of rhCC10 administered is 0.5 micrograms to 370 micrograms per day. 
     
     
       17. The method of  claim 12  wherein the rhCC10 is administered three times per day. 
     
     
       18. The method of  claim 12  wherein the rhCC10 is administered two times per day. 
     
     
       19. The method of  claim 12  wherein the rhCC10 is administered to the nasal passages by instillation, lavage, swab applicator, or spray. 
     
     
       20. The method of  claim 12  wherein the rhCC10 is administered in combination with an antibiotic, an anti-histamine, a decongestant, a mucolytic, an analgesic, a local-acting vasoconstrictor, a leukotriene receptor antagonist, a steroid, a nasal excipient, or any combination thereof. 
     
     
       21. The method of  claim 12 , wherein the rhCC10 is administered at a concentration of 250 micrograms per milliliter in 0.65% sodium chloride, disodium phosphate, phenylcarbinol, monosodium phosphate, and benzalkonium chloride at a pH of 4.0-8.0. 
     
     
       22. The method of  claim 12  wherein rhCC10 is administered in the pharmaceutical composition in a dosage of 20-50 micrograms per nostril up to four times per day. 
     
     
       23. A method of treating chronic or recurrent bacterial sinus infection in a patient comprising: administering rhCC10 at a concentration no greater than 2 milligrams/milliliter onto an intranasal mucosal membrane of a patient. 
     
     
       24. The method of  claim 23  wherein the amount of rhCC10 administered is between 1.5 micrograms and 1.5 milligrams per day. 
     
     
       25. The method of  claim 23  wherein the amount of rhCC10 administered is less than 1.1 milligrams per day. 
     
     
       26. The method of  claim 23  wherein the amount of rhCC10 administered is 0.75 micrograms to 650 micrograms per day. 
     
     
       27. The method of  claim 23  wherein the amount of rhCC10 administered is 0.5 micrograms to 370 micrograms per day. 
     
     
       28. The method of  claim 23  wherein the rhCC10 is administered three times per day. 
     
     
       29. The method of  claim 23  wherein the rhCC10 is administered two times per day. 
     
     
       30. The method of  claim 23  wherein the rhCC10 is administered to the nasal passages by instillation, lavage, swab applicator, or spray. 
     
     
       31. The method of  claim 23  wherein the rhCC10 is administered in combination with an antibiotic, an anti-histamine, a decongestant, a mucolytic, an analgesic, a local-acting vasoconstrictor, a leukotriene receptor antagonist, a steroid, a nasal excipient, or any combination thereof. 
     
     
       32. The method of  claim 23 , wherein the rhCC10 is administered at a concentration of 250 micrograms per milliliter in 0.65% sodium chloride, disodium phosphate, phenylcarbinol, monosodium phosphate, and benzalkonium chloride at a pH of 4.0-8.0. 
     
     
       33. The method of  claim 23  wherein rhCC10 is administered in the pharmaceutical composition in a dosage of 20-50 micrograms per nostril up to four times per day. 
     
     
       34. A method of treating sinus pain caused by infection in a patient comprising: administering rhCC10 at a concentration no greater than 2 milligrams/milliliter onto an intranasal mucosal membrane of a patient. 
     
     
       35. The method of  claim 34  wherein the amount of rhCC10 administered is between 1.5 micrograms and 1.5 milligrams per day. 
     
     
       36. The method of  claim 34  wherein the amount of rhCC10 administered is less than 1.1 milligrams per day. 
     
     
       37. The method of  claim 34  wherein the amount of rhCC10 administered is 0.75 micrograms to 650 micrograms per day. 
     
     
       38. The method of  claim 34  wherein the amount of rhCC10 administered is 0.5 micrograms to 370 micrograms per day. 
     
     
       39. The method of  claim 34  wherein the rhCC10 is administered three times per day. 
     
     
       40. The method of  claim 34  wherein the rhCC10 is administered two times per day. 
     
     
       41. The method of  claim 34  wherein the rhCC10 is administered to the nasal passages by instillation, lavage, swab applicator, or spray. 
     
     
       42. The method of  claim 34  wherein the rhCC10 is administered in combination with an antibiotic, an anti-histamine, a decongestant, a mucolytic, an analgesic, a local-acting vasoconstrictor, a leukotriene receptor antagonist, a steroid, a nasal excipient, or any combination thereof. 
     
     
       43. The method of  claim 34 , wherein the: rhCC10 is administered at a concentration of 250 micrograms per milliliter in 0.65% sodium chloride, disodium phosphate, phenylcarbinol, monosodium phosphate, and benzalkonium chloride at a pH of 4.0-8.0. 
     
     
       44. The method of  claim 34  wherein rhCC10 is administered in the pharmaceutical composition in a dosage of 20-50 micrograms per nostril up to four times per day. 
     
     
       45. A method of: treating rhinosinusitis caused by infection, slowing growth or regrowth of nasal polyps caused by infection, treating chronic or recurrent bacterial sinus infection, or treating sinus pain caused by infection in a patient comprising administering rhCC10 via a squeeze spray bottle, pump action spray device, metered dose nasal actuator, syringe-type instillation device, nasal swab applicator, or “Neti pot” lavage to the surfaces of the nasal passages.

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